{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65068",
      "recalling_firm": "Custom Spine, Inc.",
      "address_1": "1140 Parsippany Blvd Ste 201",
      "address_2": "N/A",
      "postal_code": "07054-1887",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide Distribution including Nebraska and Virginia.",
      "recall_number": "Z-1819-2013",
      "product_description": "Custom Spine ISSYS LP Inverted Screw System.  8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile.  Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ  07054 USA.  TEL: 973-808-0019    The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.",
      "product_quantity": "18 units",
      "reason_for_recall": "On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification.  The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm.",
      "recall_initiation_date": "20130328",
      "center_classification_date": "20130729",
      "termination_date": "20131024",
      "report_date": "20130807",
      "code_info": "Catalog Number 048545; Lot Number L363",
      "more_code_info": ""
    }
  ]
}